Lack of evidence—the anti-stepwise introduction of metal-on-metal hip replacements

Full Te ms & Condi ions o access and use can be ound a h p://www. and online.com/ac ion/jou nalIn o ma ion?jou nalCode=io 20 Download by: [Tampe e Uni e si y] Da e: 04 Oc obe 2017, A : 04:58 Ac a O hopaedica ISSN: 1745-3674 (P in ) 1745-3682 (Online) Jou nal homepage: h p://www. and online.com/loi/io 20 Lack o e idence— he an i-s epwise in oduc ion o me al-on-me al hip eplacemen s Aleksi Rei o, La i Leh o i a, Olli Lainiala, Keijo Mäkelä & An i Eskelinen To ci e his a icle: Aleksi Rei o, La i Leh o i a, Olli Lainiala, Keijo Mäkelä & An i Eskelinen (2017) Lack o e idence— he an i-s epwise in oduc ion o me al-on-me al hip eplacemen s, Ac a O hopaedica, 88:5, 478-483, DOI: 10.1080/17453674.2017.1353794 To link o his a icle: h p://dx.doi.o g/10.1080/17453674.2017.1353794 © 2017 The Au ho (s). Published by Taylo & F ancis on behal o he No dic O hopedic Fede a ion. View supplemen a y ma e ial Published online: 18 Jul 2017. Submi you a icle o his jou nal A icle iews: 393 View ela ed a icles View C ossma k da a 478 Ac a O hopaedica 2017; 88 (5): 478–483 Lack o e idence— he an i-s epwise in oduc ion o me al- on-me al hip eplacemen s A sys ema ic e iew and a compa a i e assessmen o he li e a u e and egis- y da a Aleksi REITO 1, La i LEHTOVIRTA 1,2, Olli LAINIALA 1, Keijo MÄKELÄ 3, and An i ESKELINEN 1 1 Coxa Hospi al o Join Replacemen , Tampe e, 2 Tampe e Uni e si y, Tampe e, 3 Tu ku Uni e si y Hospi al, Tu ku, Finland Co espondence: aleksi. ei o@ i mne . i Submi ed 2017-01-19. Accep ed 2017-03-31. © 2017 The Au ho (s). Published by Taylo & F ancis on behal o he No dic O hopedic Fede a ion. This is an Open Access a icle dis ibu ed unde he e ms o he C ea i e Commons A ibu ion-Non-Comme cial License (h ps://c ea i ecommons.o g/licenses/by-nc/3.0) DOI 10.1080/17453674.2017.1353794 Backg ound and pu pose — O hopedics and especially join eplacemen su ge y ha e had mo e han hei ai sha e o unsuccess ul inno a ions ha ha e iola ed widely endo sed p in- ciples o he in oduc ion o new su gical inno a ions. We aimed o in es iga e (1) he ends in he use o he Bi mingham Hip Resu acing (BHR), he ASR hip esu acing (ASR HRA) and he ASR XL o al hip eplacemen (ASR XL THR) sys em wi h e y di e en ma ke app o al p ocesses and (2) whe he hei use was co obo a ed by clinical ials published in he pee - e iewed li e a u e. Me hods — The li e a u e was sea ched o any clinical s ud- ies ha epo ed ou comes o he BHR, ASR HRA and ASR XL THRs. Da a om 7 na ional hip a h oplas y egis e s we e col- lec ed and he numbe o annually implan ed de ices was ma ched o hose epo ed in he li e a u e. Resul s — The cumula i e numbe o implan ed and pub- lished BHRs g ew p opo ionally wi h a small lag. The g ow h o implan ed BHRs s a ed o decline a he same ime as he ASR HR was in oduced. Wi h ega d o ASR HRAs, he cumula i e p opo ion o implan ed hips and hose included in he published s udies g ew disp opo iona ely a e he in oduc ion o he ASR in 2003. Fo ASR XL THRs, he disp opo ionali y is e en highe . In e p e a ion — The adop ion o ASR hip eplacemen s did no ollow he p oposed s epwise in oduc ion o o hopedic implan s. The adop ion and use o any new implan should ollow a s ic guideline and algo i hm e en i he heo e ical basis o he esul s o p eclinical s udies a e excellen . ■ The e y ounda ion o cu en heal h ca e managemen is o ha e a obus , e idence-based app oach. The IDEAL Collabo- a ion (Idea, De elopmen , Explo a ion, Assessmen , Long- e m ollow-up) p oposes ha such an app oach is cha ac e - ized by: “ he p omo ion o unbiased, highly eliable ypes o e idence” (Ba kun e al. 2009). A p agma ic app oach aken by Haynes (1999) s a es ha any inno a ion should wo k unde ideal ci cums ances (“Can i wo k?”) as well as he usual ci cums ances (“Does i wo k in p ac ice?”). Un o u- na ely, o hopedics and especially he i eld o join eplace- men su ge y ha e had mo e han hei ai sha e o unsuccess- ul inno a ions ha ha e iola ed hese p inciples. A de ailed s epwise algo i hm o he in oduc ion o new o hopedic implan s was es ablished by Malchau (Malchau 2000, Malchau e al. 2011). All new implan s should go h ough a igo ous 4-s ep in oduc ion p ocess: p eclinical s ep and clinical s eps 1–3. The p eclinical s ep includes p e- clinical es ing, i.e., in hip simula o s (“Can i wo k?”). Ve y simila guidelines ela ed o he ca as ophic ailu e o he 3M Capi al Cemen ed Hip Sys em in England in he 1990s we e ou lined by he Royal College o Su geons o England (RCS) (2001). In he ea ly 2000s, he Food and D ug Adminis a ion (FDA) in he Uni ed S a es exemp ed new de ices om clini- cal ials i manu ac u e s could p o e simila i y o ano he p oduc al eady on he ma ke (Cohen 2012, Day e al. 2016). In he Eu opean Union, a simila p o ocol was ollowed which g an ed app o al (CE label) o any me al-on-me al (MoM) hip implan as long as he manu ac u e was able o show simi- la i y o a p oduc al eady on he ma ke (Cohen 2012). Due o he simila i y be ween he wo app o al p ocedu es, in many cases he in oduc ion o MoM implan s in he Uni ed S a es and he Eu opean Union ailed o mee any o he Clinical S ep 1 p ocesses ou lined by Malchau e al. (2011), namely, open p ospec i e s udies (usual ci cums ances, “Does i wo k?”). The A icula Su ace Replacemen (ASR) MoM hip esu ac- ing (HR) sys em and he ASR XL o al hip eplacemen (THR) implan (Depuy O hopaedics, Wa saw, IN), bo h o which led o ca as ophic esul s, and many o he hip esu acing and la ge-diame e MoM THR designs we e in oduced claim- 11222 Rei o D.indd 47811222 Rei o D.indd 478 8/3/2017 2:28:24 PM8/3/2017 2:28:24 PM Downloaded by [Tampe e Uni e si y] a 04:58 04 Oc obe 2017 Ac a O hopaedica 2017; 88 (5): 478–483 479 ing simila i y o o he MoM implan s o hei cha ac e is ics al eady on he ma ke (U.S. FDA 2005, 2008). In con as , he Bi mingham Hip Resu acing (BHR, Smi h & Nephew, Wa saw, IN) sys em and he Conse e+ (W igh , Memphis, TN) implan we e he i s second-gene a ion MoM hip esu - acing designs on he ma ke o unde go ho ough p eclinical and clinical es ing (U.S. FDA 2006a, 2006b). Ou main hypo hesis is ha he ASR hip eplacemen sys em was adop ed in o use a oo apidly and lacked he suppo o clinical esul s om published s udies in he pee - e iewed li e a u e. Hence, in his pape we aim o in es iga e (1) he ends in he use o he BHR and ASR hip eplacemen s and (2) whe he hei use was co obo a ed by clinical ials pub- lished in he pee - e iewed li e a u e. Ma e ials and me hods The MoM hip eplacemen b ands in es iga ed 3 di e en MoM hip a h oplas y b ands we e in es iga ed: he BHR implan , he ASR HRA and he ASR XL THR implan s. Iden i i ca ion o s udies We sea ched o clinical s udies in he PubMed and Scopus da abases. The sea ch s a egies and he PRISMA l ow cha o he s udy selec ion a e shown in Supplemen a y da a, i les 1–3. Inclusion and exclusion c i e ia A s udy was eligible i (1) i included an o iginal pa ien coho ope a ed on wi h ei he he BHR, ASR HRA o ASR XL THR implan s and, (2) he s udy clea ly epo ed su i al a e, e i- sion a e o a ailu e a e. We de i ned an o iginal pa ien coho as a popula ion o pa ien s ollowed o a disclosed pe iod and p ima ily ope a ed on wi h a ce ain implan wi hin a ce ain ime in e al a a disclosed hospi al(s). I mo e han 1 implan was used and he numbe o pa ien s o each implan was no gi en, he s udy was excluded. Fu he mo e, a s udy was excluded i (1) i included pa ien s e e ed om somewhe e o he han he hospi al(s) whe e he s udy was ca ied ou ( io- la ion o eligibili y c i e ia 1), o (2) mo e han 1 implan was used bu he e isions we e no s a i i ed by he implan . I a s udy included a s udy a m o a subcoho o a s udy a m ha had been included in a p e ious s udy wi h di e - en ollow-up pe iods, bo h s udies we e included since hese we e conside ed sepa a e epo s. All he eco ds e ie ed om he 2 da abases using ou sea ch s a egy we e sc eened. The sc eening o abs ac s was done by wo o he au ho s (AR and LL). All s udies ha ou - lined he use o any MoM hip implan o a hip implan unde a b and name along wi h any clinical ou come (pa ien - epo ed ou come sco e, su i al a e, ailu e a e, complica ion a e, e ision a e, dea hs, me al ion le els, c oss-sec ional imag- ing i ndings) we e selec ed o ull- ex e iew and eligibili y assessmen . Re ie al and eligibili y assessmen was done by he i s au ho (AR). Da a ex ac ion No de ailed da a ex ac ion was ca ied ou . The only da a eco ded we e he numbe o hips included, he publica ion yea and he ype o implan used. Regis y da a Da a we e collec ed om he Aus alian O hopaedic Asso- cia ion Na ional Join Replacemen Regis y (AOANJRR), he Na ional Join Regis y o England and Wales (NJR), he Swedish Hip A h oplas y Regis e (SHAR), he Finnish A h oplas y Regis e (FAR), he New Zealand Join Regis y (NZJR), he Danish Hip A h oplas y Regis e (DHR) and he No wegian A h oplas y Regis e (NAR). The annual epo s a ailable in he websi es o espec i e egis ies we e sc eened and he numbe s o BHR, ASR hip esu acings and ASR XL THR annually implan ed we e eco ded. Da a om he FAR we e e ie ed di ec ly. Full his o ical da a on he use o he BHR we e a ailable om he AOANJRR, SHAR, FAR, NZJR, DHR and NAR. The annual epo o he NJR was i s published in 2004. The e o e, da a on he annual numbe o implan ed BHRs in England and Wales be ween 1997 and 2002 we e lacking. Full his o ical da a on he use o he ASR hip eplacemen s was a ailable om all 7 egis ies. S a is ics Da a om published s udies and egis ies we e collec ed yea ly ending in 2013. Since ASR hip eplacemen s we e ecalled by he manu ac u e in Sep embe 2010 and hei use hal ed in 2011 a he la es , u he da a collec ion was no deemed ea- sible. The annual inc ease in bo h he implan ed hips epo ed in he egis ies and he inc ease in he hips included in he published clinical s udies we e calcula ed. Fo each yea , a unning cumula i e p opo ion o implan ed and epo ed hips was calcula ed. This was achie ed by di iding he cumula i e numbe o implan ed and epo ed hips in each yea by he o al cumula i e numbe in he yea 2013. Following his, he p o- po ion o bo h implan ed and epo ed hips was 1.0 in 2013 and smalle in he p eceding yea s. The p ima y a iable o in e es was a ime se ies consis ing o cumula i e numbe o implan ed and epo ed hips as desc ibed abo e. Resul s 89 s udies we e iden i i ed. The de ails o all s udies included a e lis ed in Supplemen 4. In he AOANJRR, NJR, FAR and DHR, he g ow h in implan ed BHRs s a ed o decline a he ime he ASR HRA was i s in oduced. Mo eo e , he use o he BHR peaked 1 o 2 yea s p io o he peak in use o he ASR HRA (Figu e 1). 11222 Rei o D.indd 47911222 Rei o D.indd 479 8/3/2017 2:28:24 PM8/3/2017 2:28:24 PM Downloaded by [Tampe e Uni e si y] a 04:58 04 Oc obe 2017 480 Ac a O hopaedica 2017; 88 (5): 478–483 The end in he use o he BHR was simila ac oss AOAN- JRR, NJR, SHAR and FAR (Figu e 2). In he 3 o he egis- ies a iable pa e ns we e seen. The p opo ion o o he HR designs, especially he ASR HRA, inc eased apidly om 2004. Howe e , in 2010 he p opo ion o BHRs s a ed o ise and he use o ASR came o an end due o he ecall in Sep- embe 2010. In he s udies ha epo ed he esul s o he 3 implan s, he numbe o hips included in he s udies a ied g ea ly om yea o yea (Supplemen a y da a i le 5). Figu e 3 shows he ela i e p opo ion o epo ed and implan ed hips annually. In 2013, bo h cumula i e p opo - ions eached 100% o a a io o 1.0 (see Figu e 3). Wi h he BHRs, a s eady g ow h in he hips included in he published 4,000 3,000 2,000 1,000 0 2003 2005 2007 2009 2011 2013 Annually implan ed hips (NJR) BHR ASR HRA ASR XL 1,500 1,000 500 0 2001 20052003 2007 2009 2011 2013 Annually implan ed hips (AOANJR) 150 100 50 0 2000 20042002 2006 2008 2010 2012 Annually implan ed hips (SHAR) 400 300 200 100 0 20032001 2005 2007 2009 2011 2013 Annually implan ed hips (FAR) 200 150 100 50 0 2004 2006 2008 2010 2012 Annually implan ed hips (NZJR) 100 75 50 25 0 20062004 2008 2010 2012 Annually implan ed hips (NHR) 100 75 50 25 0 20072005 2009 2011 2013 Annually implan ed hips (DHR) Figu e 1. Annual implan ed Bi mingham Hip Resu ac- ings (BHR), A icula Su ace Replacemen hip esu acings (ASR HRA) and ASR XL o al hip a h oplas ies (ASR XL) in 7 egis ies be ween 1999–2013: NJR, AOANJR, SHAR, FAR,) NZJR, NHR, and DHR. 1.00 0.75 0.50 0.25 0.00 P opo ion o HRA b ands (NJR) ASR BHR o he 2003 2005 2007 2009 2011 2013 1.00 0.75 0.50 0.25 0.00 P opo ion o HRA b ands (AOANJR) 2000 2002 20062004 2008 2010 2012 1.00 0.75 0.50 0.25 0.00 P opo ion o HRA b ands (SHAR) 2000 2002 20062004 2008 2010 2012 1.00 0.75 0.50 0.25 0.00 P opo ion o HRA b ands (FAR) 2001 2003 20072005 2009 2011 2013 1.00 0.75 0.50 0.25 0.00 P opo ion o HRA b ands (NZJR) 2004 2006 2008 2010 2012 1.00 0.75 0.50 0.25 0.00 P opo ion o HRA b ands (NHR) 2004 2006 2008 2010 2012 1.00 0.75 0.50 0.25 0.00 P opo ion o HRA b ands (DHR) 2004 2006 2008 2010 2012 Figu e 2. Yea ly p opo ion o HRA b ands in he egis ies: NJR, AOANJR, SHAR, FAR, NZJR, NHR, and DHR. 11222 Rei o D.indd 48011222 Rei o D.indd 480 8/3/2017 2:28:24 PM8/3/2017 2:28:24 PM Downloaded by [Tampe e Uni e si y] a 04:58 04 Oc obe 2017 Ac a O hopaedica 2017; 88 (5): 478–483 481 s udies was seen, bu in 2007 a apid inc ease occu s which ma ches he o e all g ow h in implan ed hips. Wi h ega d o ASR HRAs and ASR XL THRs, he cumula i e p opo - ions o implan ed hips and hose included in he published s udies g ew disp opo iona ely a e he in oduc ion o he ASR in 2003. The i s s udy ha included pa ien s ope a ed on wi h he ASR XL THR was published in 2010 (Lang- on e al. 2010). In he same yea , he ASR hip sys em was ecalled. Discussion An e idence-based app oach o he in oduc ion o su gical inno a ions is undamen al (Table 1) (Haynes 1999, Mal- chau 2000, McCulloch e al. 2009). This is especially ue o join eplacemen su ge y since “ he p obabili y o success o mode n inno a ions is e y low due o he long- e m success enjoyed by con empo a y THA”, as Malchau e al. (2011) s a ed, and as also s essed by he Balliol Collabo a ion behind he IDEAL guidelines (McCulloch e al. 2009). Un o una ely, he i eld o join eplacemen su ge y has expe ienced e y li le success in achie ing a igo ous s epwise in oduc ion p ocess (Nieuwenhuijse e al. 2014). The “3M disas e ” s uck he UK in 1990 (Royal College o Su geons o England 2001). The 3M Capi al Hip was in ended o be simila o he Cha n- ley Hip wi h only sligh modi i ca ions. These sligh modi i ca- ions had, howe e , a subs an ial ad e se e ec on he su i al o he implan , and i was subsequen ly ecalled. The cu en MoM disas e is he esul o an iden ical se ies o ca as ophic mis akes (Cohen 2011, 2012). The open p ospec i e s udies equi ed in Clinical S eps 1 and 2 o he s epwise in oduc- ion o implan s sugges ed by Malchau (2000) and he clinical ials in he RCS 2001 ecommenda ion a e he esponsibili y o indi idual su geons. The FDA app o ed he BHR h ough p ema ke app o al (PMA) (U.S. FDA 2006, 2009). The ASR XL THR, on he o he hand, gained he 510(k) clea ance ha elies on “p oo o simila i y” and is mos o en ob ained by non-clinical es s. Mo eo e , he 510(k) applica ion mus s a e ha de ices a e subs an ially equi alen . In 2005, he FDA app o ed he “ASR Ace abula Cup sys em”, which in oduced a MoM THR wi h emo al head sizes o 39 o 55 mm (U.S. FDA 2005). The p edica e de ices in he applica ion, i.e., he de ices wi h which simila i y was claimed, we e he Pinnacle MoM THR and he TRANSCEND MoM THR. In e es ingly, he wo k by A daugh e al. (2013) shows ha he ances y o hese 2 de ices goes as a back as he McKee–Fa a hip and Ring hip p os heses. As la e as 2008, he FDA clea ed an ex ension o he “ASR Ace abula Cup Sys em”, namely he “ASR XL Ace abula Sys em” ha in oduced emo al head sizes o 55 o 63 mm. The “ASR Ace abula Cup Sys em” was named as a p edica e de ice along wi h he TRANSCEND MoM THR and he “ASR 300 Ace abula Cup sys em”, o which he la e had unde gone no mechanical o clinical es s (U.S. FDA 2007, A daugh e al. 2013). The ASR HRA was no , howe e , app o ed by he FDA. In e es ingly, he ASR emo al head designed o use in hemia h oplas y su ge y was app o ed using he p e ious poo ly su i ed TARA implan as he equi alen de ice. Con o e sially, al hough he ASR HRA was no app o ed by he FDA, i was g an ed a CE ma king in he Eu opean Union (Cohen 2011, House o Commons Sci- ence and Technology Commi ee 2012). Basically, a concep ual model o a heal hy adop ion o an inno a ion is a bell-shaped cu e when he po en ial ma ke sha e is depic ed as desc ibed in “Di usion o Inno a ions” by Roge s in 1962 and which was also co-adop ed in su gical inno a ions by Wilson (2006). The adop ion o he ASR XL THA in some egis e s was clea ly oo as , and in some egis- e s he adop ion phase can e en be conside ed o be missing. 1.00 0.75 0.50 0.25 0.00 Cumula i e p opo ion BHR implan ed BHR epo ed 2002 2004 20082006 2010 2012 1.00 0.75 0.50 0.25 0.00 Cumula i e p opo ion ASR implan ed ASR epo ed 2002 2004 20082006 2010 2012 1.00 0.75 0.50 0.25 0.00 Cumula i e p opo ion ASR XL implan ed ASR XL epo ed 2002 2004 20082006 2010 2012 Figu e 3. Annual cumula i e p opo ion (b own lines) o implan ed Bi mingham Hip Resu acings (BHR), A icula Su ace Replacemen hip esu acings (ASR), and ASR XL o al hip a h oplas ies (ASR XL) acco ding o egis ies and annual cumula i e numbe o hips epo ed in he pee - e iewed li e a u e ( ed lines), i.e., when 50% o he o al cumula i e numbe o BHRs we e implan ed in 2006, app oxima ely 10% o all pa ien s included in he pee - e iewed s udies we e a ailable in he li e a u e, when 90% o he o al cumula i e numbe o ASR HRAs we e implan ed in 2008, app oxima ely 10% o all pa ien s included in he pee - e iewed s udies we e a ailable in he li e a u e, and when 95% o he o al cumula i e numbe o ASR XL THAs we e implan ed in 2008, app oxima ely 0% o all pa ien s included in he pee - e iewed s udies we e a ailable in he li e a u e. 11222 Rei o D.indd 48111222 Rei o D.indd 481 8/3/2017 2:28:31 PM8/3/2017 2:28:31 PM Downloaded by [Tampe e Uni e si y] a 04:58 04 Oc obe 2017 482 Ac a O hopaedica 2017; 88 (5): 478–483 This is mos likely due o he ma ke ing psychology, as la ge- diame e MoM THRs we e ma ke ed as being iden ical o he BHR and o he well- unc ioning HRs, and hence he adop- ion would no ha e been a p oblem. Mo eo e , la ge-diame e bea ings wi h a s em we e seen as ideal o educing disloca- ion a e, and hus hey we e easily adop ed o hose pa ien s unsui able o hip esu acing. Clea ly, his was a disas ous phase as he hip simula o s udies did no e eal he in i o e ec s o inc eased modula i y ( ape – unnion in e ace) and subsequen wea (Ma hies e al. 2013). The use o he BHR dec eased quickly a e he in oduc- ion o he ASR HRA. Mo eo e , he e was a clea shi in he use o he hip esu acing concep away om he BHR, wi h nume ous s udies a ailable a he ime, o o he HR designs, mainly ASR. The adop ion o he ASR hip esu acing de ice was qui e apid. Again, his was mos likely an indus y- d i en change since he simila i y be ween he 2 was hea ily emphasized, and because simila i y was also a c ucial s ep in he app o al p ocess. Ye again, his was a disas ous phase as he hip simula o s udies did no e eal he in i o e ec s o educed clea ance and especially he educed cup hemi- sphe ici y on he wea o he bea ing couple in he ASR hip (Unde wood e al. 2012, Ma hies e al. 2014). The IDEAL guidelines s a e ha a e he i s s age (“Idea”) comes s age 2a (“De elopmen ”). The collabo a ion behind he IDEAL guidelines demands ha “p ospec i e de elop- men s udies” a e pe o med in s age 2a (Table 1). This can be conside ed equal o he demand o open p ospec i e s udies p oposed by Malchau (2000, 2011). Clea ly, phase 2a in he IDEAL guidelines and he i s clinical s ep in he Malchau algo i hm was oo apid o e en lacking du ing he shi om he BHR o o he HR designs, especially ASR HRA. When da a om he egis ies and om he li e a u e a e combined, ob ious conclusions can be d awn. In an op imal si ua ion, he numbe o s udies and pa ien s included would ma ch how much he cu en inno a ion is used. The assump- ion is ha as he adop ion o an inno a ion sp eads, he mo e people a e likely o epo he esul s o he inno a ions. Howe e , a e a ce ain le el o adop ion and sp eading, a con inuous l ow o s udies is no needed since he esul s will mos likely be he same. Wi h he BHR he e was a su i cien numbe o s udies ha included adequa e numbe s o pa ien s Table 1. Compa ison and sugges ed equali y o 3 di e en ecommenda ions ela ed o in oduc ion o o hopedic inno a ions S epwise in oduc ion o new implan echnology E alua ion and s ages o su gical Recommenda ions abou he design and inno a ions clinical e alua ion o hip p os hesis Ini ial s ep = p eclinical es ing S ages 0–1 = Inno a ion Phase I = P eclinical ials “… he p eclinical es ing migh inc ease bo h “p e-human wo k and de elopmen ” “Full e alua ion equi es ho ough p e-clinical he e i cacy and he sa e y o he inno a ion,…” “Single digi , highly selec ed pa ien s” ials, e.g., by adio-s e eome ic analysis o “pa ien sa e y can o en be imp o ed s em mig a ion,…” h ough i e a i e animal s udies, use o simula o s o augmen ed eali y” Clinical s ep 1 = P ospec i e andomized s udies S age 2a = De elopmen Phase II = Clinical ials “open p ospec i e and p e e ably andomized “a emp s o eplica e eliably ea ly “Ideally, andomized con olled ials should be ial ha includes a minimum o pa ien s bu esul s should be made” ca ied ou o e alua e he pe o mance o yields a ele an e alua ion” p os heses used o o al hip eplacemen .” “Resul s om his i s s ep de e mine whe he u he clinical e alua ion is wo hwhile” S age 2b = Clinical s ep 2 = Mul icen e s udies Ea ly dispe sion and explo a ion “exposing he new p ocedu e o a b oade “enough epo s ha e been published o aspec in he o hopaedic communi y” he echnology o be gene ally ega ded as sa e and i is s a ing o lose i s expe imen al cha ac e ” S age 3 = Assessmen “The p ocedu e is now pa o many su geons’ p ac ices “ “ esul s ha e no been desc ibed in p e iously excluded g oups” S age 4 = Long- e m implemen a ion Clinical s ep 3 = Regis e s udies and moni o ing Phase III = Pos -ma ke ing su eillance “ o include a con inuous con ol g oup by “su geons o moni o la e o a e “Th ee al e na i es cu en ly exis : using egis e s udies based on la ge coho s ou comes” (a) a egis y; (b) pos -ma ke clinical ials; o e eal ea ly o unusual and po en ial and (c) ad hoc analysis o ad e se inciden s clinical ca as ophic complica ions” and use expe ience.” “I is he e o e ecommended ha a na ional hip egis y should be es ablished.” 11222 Rei o D.indd 48211222 Rei o D.indd 482 8/3/2017 2:28:32 PM8/3/2017 2:28:32 PM Downloaded by [Tampe e Uni e si y] a 04:58 04 Oc obe 2017 Ac a O hopaedica 2017; 88 (5): 478–483 483 o p o ide e idence o i s use ollowing he yea s o in oduc- ion, a leas in male pa ien s. To sum up, in he case o BHR we pos ula e ha he e was causali y be ween he egis y and li e a u e da a meaning ha he numbe s epo ed in he egis- y p edic ed he numbe s epo ed in he li e a u e. Fo he ASR hip eplacemen , he e is basically no e idence suppo ing i s use. The use o ASR hip esu acing peaked in 2007. P io o 2007, only 1 s udy had been published (Siebel e al. 2006). The disp opo ionali y and lack o causali y be ween he ac ual use and he e idence is e en mo e ca as ophic wi h he ASR XL THR. The concep was adop ed ex emely quickly iola ing he IDEAL guidelines and he Malchau algo i hm as he e was no e idence in he pee - e iewed li e a u e o sup- po hei use. Bo h implan s show a clea delay o a lag and he lack o a s eady l ow o s udies in he pee - e iewed li e a- u e ollowing he in oduc ion o he implan s. Ou s udy is no wi hou limi a ions. The use o he ASR was also e iden in No h Ame ica. Since we a e lacking openly a ailable egis y da a om he USA and Canada, he global ends canno be di ec ly in e ed om ou da a. Second, indi- idual egis ies show some a ia ion in he use o implan s and hence he se e i y o he iola ion o he in oduc ion p o- cess a ies be ween coun ies. To conclude, he in oduc ion o he ASR hip eplacemen iola ed he undamen al p inciples o adop ion by an almos comple e lack o s udies in he pee - e iewed li e a u e ollow- ing i s in oduc ion. The esul s ob ained wi h hip simula o s, he claims o simila i y o o equi alence wi h o he implan s and heo e ical ad an ages ailed ca as ophically o subs i u e o he mos undamen al ounda ion o any inno a ion: he e idence in he li e a u e. We should lea n lessons om hese ecen mis akes made wi h hip eplacemen s on a wide scale. The adop ion and use o any new inno a ion should ollow s ic guidelines and algo i hms e en i he heo e ical basis o he esul s o p eclinical s udies a e excellen . Supplemen a y da a Supplemen a y i les 1–5 a e a ailable in he online e sion o his a icle, h p://dx.doi.o g/ 10.1080/17453674.2017.1353794 AR collec ed he da a, analyzed he da a and d a ed he manusc ip . LL col- lec ed he da a and commen ed on he d a . OL collec ed he da a and com- men ed on he d a . KM commen ed on he d a . AE collec ed he da a and commen ed on he d a . All au ho s ead and app o ed he i nal manusc ip . AE has ecei ed a g an and a lec u e ee om Depuy. O he au ho s ha e no hing o disclose. Ac a hanks A ild Aamod and Ma c Nieuwenhuijse o help wi h pee e iew o his s udy. A daugh B M, G a es S E, Redbe g R F. The 510(k) ances y o a me al-on- me al hip implan . N Engl J Med 2013; 368 (2): 97-100. Ba kun J S, A onson J K, Feldman L S, Madde n G J, S asbe g S M, Balliol Collabo a ion. E alua ion and s ages o su gical inno a ions. Lance 2009; 374 (9695): 1089-96. Cohen D. Ou o join : The s o y o he ASR. BMJ 2011; 342: d2905. Cohen D. Faul y hip implan shows up ailings o EU egula ion. BMJ 2012; 345: e7163. Day C S, Pa k D J, Rozensh eyn F S, Owusu-Sa pong N, Gonzalez A. Analy- sis o FDA-app o ed o hopaedic de ices and hei ecalls. J Bone Join Su g Am 2016; 98 (6): 517-24. Haynes B. Can i wo k? Does i wo k? Is i wo h i ? The es ing o heal hca e in e en ions is e ol ing. BMJ 1999; 319 (7211): 652-3. House o Commons Science and Technology Commi ee. Regula ion o medi- cal implan s in he EU and UK. Fi h epo o session 2012-13. Lang on D J, Jameson S S, Joyce T J, Hallab N J, Na u S, Na gol A V. Ea ly ailu e o me al-on-me al bea ings in hip esu acing and la ge-diame e o al hip eplacemen : A consequence o excess wea . J Bone Join Su g B 2010; 92 (1): 38-46. Malchau H. In oducing new echnology: A s epwise algo i hm. Spine (Phila Pa 1976) 2000; 25 (3): 285. Malchau H, B agdon C R, Mu a oglu O K. The s epwise in oduc ion o inno- a ion in o o hopedic su ge y: The nex le el o dilemmas. J A h oplas y 2011; 26 (6): 825-31. Ma hies A K, Racasan R, Bills P, Blun L, C o S, Panagio idou A, Blunn G, Skinne J, Ha A J. Ma e ial loss a he ape junc ion o e ie ed la ge head me al-on-me al o al hip eplacemen s. J O hop Res 2013; 31 (11): 1677-85. Ma hies A K, Henckel J, C o S, Sua ez A, Noble P C, Skinne J, Ha A J. P edic ing wea and blood me al ion le els in me al-on-me al hip esu ac- ing. J O hop Res 2014; 32 (1): 167-74. McCulloch P, Al man D G, Campbell W B, Flum D R, Glasziou P, Ma shall J C, Nicholl J, Balliol Collabo a ion. No su gical inno a ion wi hou e alu- a ion: The IDEAL ecommenda ions. Lance 2009; 374 (9695): 1105-12. Medicines and Heal hca e P oduc s Regula o y Agency. Medical de ice ale . Me al-on-me al (MoM) hip eplacemen s: Bi mingham hip™ esu - acing (BHR) sys em (Smi h & Nephew o hopaedics). June 25, 2015; MDA/2015/024. Nieuwenhuijse M J, Nelissen R G, Schoones J W, Sed akyan A. App aisal o e idence base o in oduc ion o new implan s in hip and knee eplace- men : A sys ema ic e iew o i e widely used de ice echnologies. BMJ 2014; 349: g5133. Roge s E M. Di usion o inno a ions. New Yo k: F ee P ess, 1962. Royal College o Su geons o England. An in es iga ion o he pe o mance o he 3M™ capi al™ hip sys em. To on, UK: Hobbs he P in e s, 2001. Siebel T, Maubach S, Mo lock MM. Lessons lea ned om ea ly clinical expe ience and esul s o 300 ASR hip esu acing implan a ions. P oc Ins Mech Eng H. 2006; 220 (2): 345-53. Unde wood R J, Zog a os A, Sayles R S, Ha A, Cann P. Edge loading in me al-on-me al hips: Low clea ance is a new isk ac o . P oc Ins Mech Eng H 2012; 226 (3): 217-26. U.S. Food and D ug Adminis a ion. 2005. 510(k) p ema ke no i i ca ion: DEPUY ASR MODULAR ACETABULAR CUP SYSTEM. K040627. U.S. Food and D ug Adminis a ion. 2006a. P ema ke app o al (PMA): BIR- MINGHAM HIP RESURFACING (BHR) SYSTEM. P040033. U.S. Food and D ug Adminis a ion. 2006b. Summa y o sa e y and e ec i e- ness da a: The bi mingham hip esu acing. U.S. Food and D ug Adminis a ion. 2007. Summa y o sa e y and e ec i e- ness da a: DEPUY ASR 300 ACETABULAR CUP SYSTEM. K073413 U.S. Food and D ug Adminis a ion. 2008. 510(k) p ema ke no i i ca ion: DEPUY ASR XL MODULAR ACETABULAR CUP SYSTEM. K080991. U.S. Food and D ug Adminis a ion. 2009. P ema ke app o al (PMA): CON- SERVE PLUS TOTAL RESURFACING HIP SYSTEM. P030042. Wilson C B. Adop ion o new su gical echnology. BMJ 2006; 332 (7533): 112-14. 11222 Rei o D.indd 48311222 Rei o D.indd 483 8/3/2017 2:28:32 PM8/3/2017 2:28:32 PM Downloaded by [Tampe e Uni e si y] a 04:58 04 Oc obe 2017